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European Union › Medical Devices › United Kingdom

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Knobbe Martens

UK Proposes Approving Medical Devices Based on Approval in Other Countries

Knobbe Martens on

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

Jones Day on

In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Emery

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

McDermott Will & Emery on

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 99

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. This COVID-19 Update...more

Hogan Lovells

Safety first: MHRA response to UK medical device regulation consultation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

McDermott Will & Emery on

MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

McDermott Will & Emery

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

McDermott Will & Emery on

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

Latham & Watkins LLP on

The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

MoFo Life Sciences

Life Sciences Regulatory Framework Becomes Law Post-Brexit

MoFo Life Sciences on

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act...more

Wilson Sonsini Goodrich & Rosati

Electronic Gaming Legal Newsletter - December 2020

Wilson Sonsini Goodrich & Rosati on

Games vary in difficulty from the first levels of Candy Crush to the final bosses of Sekiro: Shadows Die Twice. They vary in visual fidelity from the ASCII characters of Dwarf Fortress to the high-detail, motion-capture shown...more

McDermott Will & Emery

Regulating Medical Devices Post Brexit

McDermott Will & Emery on

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in...more

Dechert LLP

Increased regulatory scrutiny of foreign direct investments in the healthcare sector

Dechert LLP on

Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus.  - Several countries have adapted their existing FDI rules, or...more

Hogan Lovells

EU Commission adopts Communication on Brexit including anticipated changes in the health sector

Hogan Lovells on

On 9 July 2020 the European Commission adopted a Communication regarding readiness at the end of the transition period between the European Union and the United Kingdom. ...more

McDermott Will & Emery

International News: COVID-19 Global Pandemic - May 2020

McDermott Will & Emery on

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Jones Day

Trade Controls in the EU: COVID-19 Measures at a Glance

Jones Day on

In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more

Hogan Lovells

International Products Law Review 2019: Issue 75

Hogan Lovells on

We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Emery on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

New UK MHRA No Deal Guidance

Hogan Lovells on

With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more

Hogan Lovells

Brexit snapshot: Medical Devices

Hogan Lovells on

Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in the UK? ...more

Hogan Lovells

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

Hogan Lovells on

On 1 March 2019, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

Hogan Lovells on

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

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